Koselugo approved in the EU for plexiform neurofibromas in adults with neurofibromatosis type 1

On October 28, 2025 Alexion and AstraZeneca reported that its rare disease Koselugo (selumetinib), an oral, selective MEK inhibitor, has been approved in the European Union (EU) for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in adult patients with neurofibromatosis type 1 (NF1).

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The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) and is based on results from KOMET, the largest and only placebo-controlled global Phase III trial in this patient population, which were presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and published in The Lancet.2

NF1 is a rare, progressive, genetic condition usually diagnosed in early childhood, but often progressing into adulthood, that can impact every organ system.3,4 Up to 50% of people living with NF1 may develop a type of non-malignant tumour called PN that may affect the brain, spinal cord and nerves.4,5 PN may appear later in a person’s life and can grow and become large, leading to pain, disfigurement and muscle weakness, among other debilitating symptoms.4,5

Prof. Pierre Wolkenstein, MD, PhD, Head of the Department of Dermatology at Henri Mondor Hospital, APHP, Paris East University (UPEC), and National Coordinating Investigator of the KOMET trial in Europe, said: "The approval of Koselugo for adults with NF1 PN in Europe offers patients and physicians a meaningful approach to close treatment gaps beyond childhood. As demonstrated in the KOMET Phase III trial, the most robust late-stage clinical trial conducted in this patient group to-date, adults administered Koselugo saw significant tumour volume reduction with a safety profile consistent with its established use in paediatric patients, validating the clinical benefits of Koselugo for newly diagnosed adults and those transitioning to adult care."

Marc Dunoyer, Chief Executive Officer, Alexion, said: "The European Commission approval extends the life-changing potential of Koselugo to adults with NF1 PN in the region, including continuity of care into adulthood. This milestone, along with our pioneering leadership in NF1 PN treatment landscape, embodies Alexion’s unwavering commitment to addressing the unmet needs in the rare disease community. We look forward to bringing Koselugo to those adults in need across Europe as soon as possible."

In the primary analysis of the trial, Koselugo showed a statistically significant objective response rate (ORR) of 20% (n=14/71, 95% CI: 11.2, 30.9) compared to 5% with placebo (n=4/74, 95% CI: 1.5, 13.3; p=0.01) by cycle 16. After 12 cycles, patients on placebo were switched to Koselugo and patients on Koselugo remained on treatment for an additional 12 cycles.2

The safety profile of Koselugo in the KOMET Phase III trial was consistent with its known profile and established use in paediatric patients.2

Koselugo has been recently approved in Japan and other countries for the treatment of adult patients with NF1 who have symptomatic, inoperable PN based on data from the KOMET Phase III trial, and additional regulatory reviews are ongoing.

Notes

NF1
NF1 is a rare, progressive, genetic condition that is caused by a spontaneous or inherited mutation in the NF1 gene.3,4 NF1 is associated with a variety of symptoms, including soft lumps on and under the skin (cutaneous neurofibromas) and, in up to 50% of patients, tumours called plexiform neurofibromas (PN) may develop on the nerve sheaths.4,5 These PN can cause clinical issues such as disfigurement, motor dysfunction, pain, airway dysfunction, visual impairment and bladder or bowel dysfunction.4,5

KOMET
KOMET is a global Phase III randomised, double-blind, placebo-controlled, multicentre trial designed to evaluate the efficacy and safety of Koselugo in adults with NF1 who have symptomatic, inoperable PN. The trial enrolled 145 adults from 13 countries across North America, South America, Europe, Asia and Australia, with participants’ baseline characteristics, including gender and distribution of PN, reflective of the global adult NF1 patient population. Patients were enrolled and randomised to receive Koselugo or placebo (1:1) for 12 28-day cycles. Participants were required to have diagnosis of NF1, at least one symptomatic, inoperable PN measurable by volumetric MRI analysis, chronic PN pain score documented during screening, adequate organ and marrow function and stable chronic PN pain medication use at enrolment.2,6

The primary endpoint is confirmed objective response rate (ORR) by cycle 16 as assessed by ICR. ORR is defined as the percentage of patients with confirmed complete response (disappearance of PNs) or partial response (at least 20% reduction in tumour volume). Secondary endpoints include improved PN-related pain and health-related quality of life (HRQoL) at cycle 12.2,6

After 12 cycles, patients on placebo were switched to Koselugo and patients on Koselugo remained on treatment for an additional 12 cycles. Patients who had the opportunity to complete 24 cycles of treatment have the option to participate in a long-term extension period and continue to receive Koselugo.2,6

Koselugo

Koselugo (selumetinib) is a kinase inhibitor that blocks specific enzymes (MEK1 and MEK2), which are involved in stimulating cells to grow. In NF1, these enzymes are overactive, causing tumour cells to grow in an unregulated way creating so-called plexiform neurofibromas (PN). By blocking these enzymes, Koselugo slows down the growth of tumour cells and, therefore, the PN growth.

Koselugo is approved in the US, EU, Japan, China and other countries for the treatment of certain paediatric patients with NF1 who have symptomatic, inoperable PN.

Koselugo is approved in the EU, Japan and other countries for the treatment of adult patients with NF1 who have symptomatic, inoperable PN, and additional regulatory reviews are ongoing.

Koselugo has been granted Orphan Drug Designation in the US, EU, Japan and other countries for the treatment of NF1.

(Press release, AstraZeneca, OCT 28, 2025, View Source [SID1234657076])

BeOne Medicines to Present at Upcoming Investor Conferences

On October 28, 2025 BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, reported it will participate in fireside chats at two upcoming investor conferences:

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Guggenheim Second Annual Healthcare Innovation Conference on Monday, November 10, 2025 at 9:30 am EST; and
Jefferies Global Healthcare Conference in London on Monday, November 17, 2025 at 4:00 pm GMT/11:00 am EST
Live webcasts of these events can be accessed from the investors section of the Company’s website at View Source, View Source, View Source Archived replays will be available on the Company’s website.

(Press release, BeOne Medicines, OCT 28, 2025, View Source/news/beone-medicines-to-present-at-upcoming-investor-conferences/2a85b5e9-db56-4488-b325-acec8a08ff0a [SID1234657075])

Encouraging early efficacy in CAR T naïve lymphomas in azer-cel Phase 1b trial

On October 28, 2025 Imugene Limited (ASX: IMU), a clinical-stage immuno-oncology company, reported the first efficacy results from the CAR T-naïve niche indication portion of its ongoing Phase 1b trial of azer-cel (azercabtagene zapreleucel) — an off-the-shelf, allogeneic CD19 CAR T therapy being evaluated across a spectrum of B-cell lymphomas.

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Of six evaluable CAR T-naïve patients (patients with no previous CAR T treatment), five (83%) achieved an overall response including three (50%) complete responses. The result of the sixth patient’s follow-up scan is pending.

A total of ten patients have been treated in this cohort thus far, with further results to come upon patient follow-up. These initial results encompass several rare lymphoma subtypes, notably WM, MZL and PCNSL — areas of significant unmet clinical need where no CAR T products are currently approved.

Azer-cel continues to demonstrate a manageable safety profile consistent with previously reported results in relapsed diffuse large B-cell lymphoma (DLBCL). Importantly, enrolment into the CAR T-naïve expansion is proceeding significantly faster than the earlier CAR T-relapsed DLBCL cohort, reflecting the substantial clinical demand and investigator enthusiasm for an allogeneic approach.

Imugene has an FDA Type C meeting in November to discuss pivotal study design options for azer-cel in CAR T-relapsed DLBCL, while also advancing the CAR T-naïve program to generate a broader evidence base across additional indications, including rare lymphomas to expand registrational options.

Chief Executive Officer Leslie Chong said "We are encouraged by these early signals of efficacy in the CAR T-naïve population, with at least five of the first six evaluable patients responding to treatment. As best responses can be seen up to 90 days or more after treatment, we look forward to further data on the depth and durability of these outcomes. Enrolment in this portion of the trial is proceeding at a remarkable pace, positioning us to explore an expedited development pathway for azer-cel."

In the CAR T relapsed DLBCL portion of the same Phase 1b study, azer-cel has achieved an 81% overall response rate to date, including multiple complete and partial responses, with several patients remaining in durable remission beyond a year. Patients in this cohort had typically failed an average of three prior lines of therapy, including autologous CAR T. These findings reinforce azer-cel’s potential as an allogeneic alternative for patients who relapse following existing CAR T treatments and complement the strong early data now emerging in the CAR T-naïve setting.

(Press release, Imugene, OCT 28, 2025, View Source [SID1234657074])

Regeneron Reports Third Quarter 2025 Financial and Operating Results

On October 28, 2025 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported financial results for the third quarter of 2025 and provided a business update.

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"Regeneron had a solid financial quarter and made progress across our late-stage portfolio by securing new FDA approvals for Libtayo, Evkeeza, and Lynozyfic, receiving positive CHMP opinions for Libtayo and Dupixent, and sharing promising data across our oncology, obesity, allergy, and rare disease portfolios," said Leonard S. Schleifer, M.D., Ph.D., Board co-Chair, President and Chief Executive Officer of Regeneron. "We were proud to receive one of the FDA’s first Commissioner’s National Priority Vouchers for DB-OTO for a rare form of congenital hearing loss. We also donated our Ebola treatment, Inmazeb, to countries most at risk of outbreaks, reflecting our commitment to ensuring patients in need are able to access our novel medicines."

Financial Highlights

($ in millions, except per share data) Q3 2025
Q3 2024
% Change
Total revenues $ 3,754 $ 3,721 1%
GAAP net income $ 1,460 $ 1,341 9%
GAAP net income per share – diluted $ 13.62 $ 11.54 18%
Non-GAAP net income(a) $ 1,287 $ 1,462 (12% )
Non-GAAP net income per share – diluted(a) $ 11.83 $ 12.46 (5% )

"We were pleased with our third quarter 2025 performance, which highlights the commercial strength of Dupixent, EYLEA HD, and Libtayo, and reinforces our momentum toward delivering solid financial performance for the year while advancing transformative therapies to patients around the world," said Christopher Fenimore, Executive Vice President, Finance and Chief Financial Officer of Regeneron. "Our disciplined approach to capital allocation fuels innovation through targeted investments, all while delivering value to shareholders. In the first nine months of 2025, we reaffirmed our commitment to advancing U.S. innovation and manufacturing by investing nearly $5 billion in R&D and capital expenditures, predominantly within the United States. We also returned over $3 billion to shareholders via share repurchases and dividends, underscoring our commitment to long-term value creation."

Business Highlights

Key Pipeline Progress
Regeneron has approximately 45 product candidates in clinical development, including a number of marketed products for which it is investigating additional indications. Updates from the clinical pipeline include:

Dupixent (dupilumab)

In September 2025, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of Dupixent in the European Union (EU) for the treatment of chronic spontaneous urticaria (CSU) in adults and adolescents aged 12 years and older who remain symptomatic despite antihistamine treatment. The European Commission (EC) is expected to announce a final decision in the coming months.
EYLEA HD (aflibercept) 8 mg

In October 2025, the Company was notified by Catalent Indiana, LLC (Catalent), the manufacturing filler in the EYLEA HD Biologics License Application (BLA), that they received an official action indicated (OAI) letter from the FDA citing unresolved issues related to a July 2025 FDA general site inspection (not specific to EYLEA HD).

Yesterday, the FDA issued a Complete Response Letter (CRL) for the pre-filled syringe supplemental BLA (sBLA). The sole approvability issue cited in the CRL relates to unresolved inspection findings at Catalent. The Company is planning to submit by January 2026 an application to include a new pre-filled syringe manufacturing filler in the EYLEA HD BLA.

There is also an sBLA under review by the FDA for EYLEA HD every-four-week dosing and for the treatment of macular edema following retinal vein occlusion (RVO), which has a target action date in late November 2025. In addition, the Company has submitted an application to include an additional vial filler, with an FDA decision regarding this new vial filler expected by late December 2025.
Libtayo (cemiplimab)

In October 2025, the FDA approved an sBLA for Libtayo as an adjuvant treatment for adults with CSCC at high risk of recurrence after surgery and radiation, making Libtayo the first and only immunotherapy approved in this setting. The EMA’s CHMP also adopted a positive opinion for the adjuvant treatment of CSCC, and the EC is expected to announce a final decision in the coming months.
In September 2025, Japan’s Ministry of Health, Labour and Welfare (MHLW) approved Libtayo for an additional indication, as a monotherapy and in combination with chemotherapy for the treatment of adult patients with unresectable advanced or relapsed non-small cell lung cancer (NSCLC).
In September 2025, the Company announced five-year follow-up results on overall survival from a Phase 3 trial, which evaluated Libtayo plus platinum-based chemotherapy versus chemotherapy alone as a first-line treatment for adults with locally advanced or metastatic NSCLC. The data demonstrate a more than double five-year overall survival rate of 19.4%, compared to 8.8% with chemotherapy alone, and was presented at the IASLC 2025 World Conference on Lung Cancer.
Other Programs

In August 2025, the Company announced that the primary and key secondary endpoints were met in a Phase 3 trial of cemdisiran (siRNA therapy), as both a monotherapy and in combination with pozelimab (C5 antibody), in adults with generalized myasthenia gravis. Cemdisiran monotherapy was numerically better than the combination treatment across these endpoints, showing a statistically significant 2.3-point placebo-adjusted improvement in Myasthenia Gravis Activities of Daily Living (MG-ADL) total score. A U.S. regulatory submission for cemdisiran monotherapy is planned for the first quarter of 2026, pending discussions with the FDA.
In October 2025, updated data from the pivotal trial of DB-OTO, an AAV-based gene therapy, in children with profound genetic hearing loss due to variants of the otoferlin (OTOF) gene were published in the New England Journal of Medicine and presented at the annual American Academy of Otolaryngology-Head and Neck Surgery meeting. These latest results from the CHORD trial show 11 out of 12 participants have experienced clinically meaningful hearing improvements. A U.S. regulatory submission for DB-OTO is planned for the fourth quarter of 2025.
In October 2025, the FDA selected DB-OTO to receive one of the Commissioner’s National Priority Vouchers, a pilot program intended to reduce the review time for certain drug and biologic applications to just one to two months.
In September 2025, the Company announced the primary endpoint was met in a Phase 3 trial of garetosmab in adults with FOP, showing a 90% or greater reduction in new bone lesions (heterotopic ossification, or HO lesions) compared to placebo at 56 weeks, and a greater than 99% reduction in the total volume of new HO lesions. A U.S. regulatory submission for garetosmab is planned for the fourth quarter of 2025.
In September 2025, the FDA approved Evkeeza (evinacumab) for the treatment of homozygous familial hypercholesterolemia (HoFH), extending the already approved indication to include children from age 1 to less than 5 years old.
In September 2025, the Company announced results from the Phase 3 trials evaluating its allergen-blocking antibodies in adults with moderate-to-severe cat allergies (REGN1908 and REGN1909) or birch allergies (REGN5713 and REGN5715). Both trials met their respective primary and key secondary endpoints, with single doses of the allergen-specific antibody blockers significantly reducing allergy symptoms compared to placebo at day 8. Additional Phase 3 development is planned to begin by the end of the year.
Corporate Updates

In September and October 2025, the Company reached resolution of its patent infringement litigation related to the Sandoz, Formycon, and Celltrion EYLEA (aflibercept) Injection 2 mg biosimilar products. The settlements preclude Sandoz, Formycon, and Celltrion from launching their biosimilar products in the United States until the fourth quarter of 2026. All intellectual property-related litigation with Sandoz, Formycon, and Celltrion in the United States has been dismissed.
Third Quarter 2025 Financial Results

Revenues

($ in millions) Q3 2025
Q3 2024
% Change
Net product sales:
EYLEA HD – U.S. $ 431 $ 392 10%
EYLEA – U.S. 681 1,145 (41% )
Total EYLEA HD and EYLEA – U.S. 1,112 1,537 (28% )
Libtayo – U.S. 219 195 12%
Libtayo – ROW* 146 94 55%
Total Libtayo – Global 365 289 26%
Praluent- U.S. 67 53 26%
Evkeeza – U.S. 43 32 34%
Other products – Global 1 35 (97% )
Total net product sales 1,588 1,946 (18% )

Collaboration revenue:
Sanofi 1,617 1,263 28%
Bayer 345 391 (12% )
Other 6 6 —%
Other revenue 198 114 74%
Total revenues $ 3,754 $ 3,720 1%

* Rest of world (ROW)

Net product sales of EYLEA HD increased in the third quarter of 2025, compared to the third quarter of 2024, due to higher sales volumes driven by increased demand, partly offset by a lower net selling price.

Net product sales of EYLEA in the third quarter of 2025, compared to the third quarter of 2024, were negatively impacted by (i) lower sales volumes as a result of continued competitive pressures, loss in market share to compounded bevacizumab due to patient affordability constraints, and the continued transition of patients to EYLEA HD, and (ii) a lower net selling price.

Sanofi collaboration revenue increased in the third quarter of 2025, compared to the third quarter of 2024, due to an increase in the Company’s share of profits from the commercialization of antibodies, which were $1.46 billion and $1.09 billion in the third quarter of 2025 and 2024, respectively. The change in the Company’s share of profits from commercialization of antibodies was driven by higher profits associated with an increase in Dupixent sales.

Refer to Table 4 for a summary of collaboration revenue.

Other revenue increased in the third quarter of 2025, compared to the third quarter of 2024, due to an increase in royalties and share of profits earned in connection with license agreements, which were $165 million and $91 million for the third quarter of 2025 and 2024, respectively.

Operating Expenses

GAAP %
Non-GAAP(a) %
($ in millions) Q3 2025 Q3 2024 Change
Q3 2025 Q3 2024 Change
Research and development (R&D) $ 1,475 $ 1,272 16 % $ 1,350 $ 1,146 18 %
Acquired in-process research and development (IPR&D) $ 83 $ 56 48 % *
*
n/a
Selling, general, and administrative (SG&A) $ 658 $ 714 (8 %) $ 541 $ 613 (12 %)
Cost of goods sold (COGS) $ 281 $ 262 7 % $ 227 $ 217 5 %
Gross margin on net product sales(b) 82% 87% 86% 89%
Cost of collaboration and contract manufacturing (COCM)(c) $ 241 $ 229 5 % *
*
n/a
Other operating (income) expense, net $ (10 ) $ 8 ** *
$ — **

* GAAP and non-GAAP amounts are equivalent as no non-GAAP adjustments have been recorded
** Percentage not meaningful

GAAP and non-GAAP R&D expenses increased in the third quarter of 2025, compared to the third quarter of 2024, driven by the advancement of the Company’s late-stage clinical pipeline.
Acquired IPR&D expenses for the third quarter of 2025 included an $80 million up-front payment in connection with the Company’s license agreement with Hansoh Pharmaceuticals Group Company Limited. Acquired IPR&D expenses for the third quarter of 2024 included a $45 million development milestone in connection with the Company’s collaboration agreement with Sonoma Biotherapeutics, Inc.
GAAP and non-GAAP SG&A expenses decreased in the third quarter of 2025, compared to the third quarter of 2024, primarily due to lower charitable contributions to an independent not-for-profit patient assistance organization.
GAAP and non-GAAP gross margin on net product sales decreased in the third quarter of 2025, compared to the third quarter of 2024, partly due to ongoing investments to support the Company’s manufacturing operations. In addition, GAAP gross margin on net product sales decreased due to higher amortization expense associated with the Company’s Libtayo intangible asset.
Other Financial Information

GAAP other income (expense), net included the recognition of net gains on marketable and other securities of $578 million in the third quarter of 2025, compared to $135 million in the third quarter of 2024.

In the third quarter of 2025, the Company’s GAAP effective tax rate (ETR) was 17.2%, compared to 10.2% in the third quarter of 2024. The GAAP ETR increased in the third quarter of 2025, compared to the third quarter of 2024, primarily due to the impact of the enactment of the "One Big Beautiful Bill Act" or "OBBBA," including a $45 million charge related to the re-measurement of the Company’s U.S. net deferred tax assets, as well as lower tax benefits from less stock option exercises. In the third quarter of 2025, the non-GAAP ETR was 13.1%, compared to 10.7% in the third quarter of 2024.

A reconciliation of the Company’s GAAP to non-GAAP results is included in Table 3 of this press release.

Capital Allocation

During the third quarter of 2025, the Company repurchased shares of its common stock and recorded the cost of the shares, or $663 million, as Treasury Stock. As of September 30, 2025, $2.156 billion remained available for share repurchases under the Company’s share repurchase programs.

In October 2025, the Company’s board of directors declared a cash dividend of $0.88 per share on the Company’s common stock and Class A stock, payable on December 5, 2025 to shareholders of record as of November 20, 2025.

2025 Financial Guidance*

The Company’s full year 2025 financial guidance consists of the following components:

2025 Guidance
Prior Updated
GAAP R&D $5.660–$5.790 billion $5.680–$5.750 billion
Non-GAAP R&D(a) $5.100–$5.200 billion $5.150–$5.200 billion
GAAP SG&A** $2.810–$2.940 billion $2.775–$2.845 billion
Non-GAAP SG&A(a)** $2.450–$2.550 billion $2.400–$2.450 billion
GAAP gross margin on net product sales Approximately 83% Approximately 82%
Non-GAAP gross margin on net product sales(a) Approximately 86% Unchanged
COCM*** $1.000–$1.050 billion $950 million–$1.000 billion
Capital expenditures*** $880–$950 million $850–$890 million
GAAP effective tax rate 11%–13% Approximately 14%
Non-GAAP effective tax rate(a) 11%–13% Approximately 12%

* The Company’s 2025 financial guidance does not assume the completion of any business development transactions not completed as of the date of this press release
** The Company’s 2025 financial guidance includes potential matching program donations to Good Days, an independent national non-profit charitable organization, to support Good Days’ Retinal Vascular and Neovascular Disease Fund

(Press release, Regeneron, OCT 28, 2025, View Source [SID1234657073])

OPKO Health’s ModeX Therapeutics Begins Clinical Trial of MDX2004 for the Treatment of Advanced Cancers

On October 28, 2025 ModeX Therapeutics Inc., an OPKO Health company (NASDAQ: OPK), reported the initiation and recent dosing of the first patient in a Phase 1/2a clinical trial (NCT07110584) with MDX2004, a first-in-class trispecific antibody-fusion protein for oncology and immune disorders. The study is designed to evaluate the safety, tolerability, and biologic activity of MDX2004 as an immunotherapy for advanced cancers.

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MDX2004 is designed to stimulate T cells through three signaling pathways to enhance immune activation. This proprietary multispecific antibody engages CD3, CD28, and 4-1BB and is expected to activate T lymphocytes, including stem and memory T cells. Because stem T cells undergo self-renewal and give rise to mature T cells, the drug aims to recruit and replenish, or "rejuvenate," cellular immunity. Unlike previous 4-1BB antibody therapies, recognition of 4-1BB by this molecule does not involve antibody binding because it binds as a ligand to the natural receptor.

"Patients with advanced solid tumors may have limited options with existing treatments, facing challenging disease control rates and low long-term survival," said Giovanni Abbadessa, M.D., Ph.D., Chief Medical Officer of ModeX. "The MDX2004 multispecific antibody aims to rejuvenate T cells and sustain an expanded immune response in a broad range of tumors. We look forward to exploring further via this clinical trial."

"We are excited to bring MDX2004 to patients as a first-in-class trispecific antibody with a unique design aiming for a specific mechanism of action. By stimulating and sustaining immune function, this T cell rejuvenator has potential to treat diverse cancers and reverse immune impairment caused by chemotherapy, chronic diseases, infection and aging," said Phillip Frost, M.D., Chairman and CEO of OPKO Health and Gary Nabel, M.D., Ph.D., President and CEO of ModeX and Chief Innovation Officer of OPKO Health.

Preclinical proof-of-concept data as well as clinical dose selection analyses to support the MDX2004 development will be showcased in two poster presentations at the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), National Harbor, MD, on November 5-9, 2025.

About MDX2004
MDX2004 is a novel trispecific antibody–fusion protein that targets CD3, CD28, and 4-1BB (CD137) on human T cells. It is designed to promote the expansion of stem and memory T cell populations, thereby rejuvenating immune function and enhancing anti-tumor immunity. This trifunctional approach aims to expand and sustain both stem and mature memory T cell subsets, which have been associated with favorable responses to immunotherapy. It may thus help restore immune function in subjects with underlying immune impairment from aging, chronic diseases such as diabetes, infections or chemotherapies.

Beyond bispecifics: ModeX Synergistic Targeting of Antibody Receptors (MSTAR)
Multispecific antibody therapeutics can help generate medicines of the future by targeting multiple disease pathways simultaneously. Many untreatable or complex conditions arise from multiple root causes; yet most medicines only act on a single target. ​​ModeX overcomes these challenges by combining natural protein structures using a platform known as the ModeX Synergistic Targeting of Antibody Receptors (MSTAR) to create unique multispecific medicines. The platform generates multispecific antibodies from modular building blocks intended to modulate potency and maximize specificity to address multiple disease pathways simultaneously.

(Press release, Opko Health, OCT 28, 2025, View Source [SID1234657072])